NCT03420924

Brief Summary

The aim of this clinical investigation is to prove that the thermal suit with forced-air warming is more effective to prevent inadvertent intraoperative hypothermia than conventional warming methods. The study group will have the thermal suit from arriving to the hospital until to the ward after surgery. In the operating theatre forced-air warming device will be connected to the trouser legs of the thermal suit and the device will be turned on during surgery. The control group will have normal hospital clothes. Intraoperative warming will be managed with the warming mattress and a forced-air warming blanket. The primary endpoint is core temperature after arriving to the post-anaesthesia care unit.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

February 20, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2018

Completed
Last Updated

October 30, 2018

Status Verified

February 1, 2018

Enrollment Period

5 months

First QC Date

January 29, 2018

Last Update Submit

October 28, 2018

Conditions

Hypothermia, Accidental

Keywords

intraoperative hypothermiathermal suitforced-air warming

Outcome Measures

Primary Outcomes (1)

  • Core temperature

    Core temperature after arriving to the post-anaesthesia care unit

    1 hour

Study Arms (2)

Thermal suit

EXPERIMENTAL
Device: Thermal suit

Conventional hospital clothes

ACTIVE COMPARATOR
Device: Conventional hospital clothes

Interventions

Thermal suitDEVICE

Forced-air warming device will be connected to the trouser legs of the thermal suit.

Thermal suit
Conventional hospital clothesDEVICE

The warming mattress and a forced-air warming blanket for the lower body will be used intraoperatively.

Conventional hospital clothes

Eligibility Criteria

Age20 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary breast cancer surgery
  • unilateral resection or mastectomy with or without axillar lymphadenectomy
  • body mass index 25-40

You may not qualify if:

  • ASA \> III
  • decreased mental status
  • inadequate Finnish language skills
  • other than general anaesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TAYS Hatanpää

Tampere, 33900, Finland

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Maija-Liisa Kalliomäki

    Tampere University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2018

First Posted

February 5, 2018

Study Start

February 20, 2018

Primary Completion

July 6, 2018

Study Completion

July 6, 2018

Last Updated

October 30, 2018

Record last verified: 2018-02

Locations

FI(1)